News about "National Medical Products Administration (NMPA)"

Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC

Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC

Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.

National Medical Products Administration (NMPA) | 03/11/2025 | By Dineshwori

Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData

Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData

China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.

National Medical Products Administration (NMPA) | 25/09/2025 | By Dineshwori

NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial

NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial

Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.

National Medical Products Administration (NMPA) | 13/09/2025 | By Dineshwori


 

 

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